Responsibilities:
● Adhere to Validation plan and procedure related to, as applicable, Qualification of Computerized Systems (OT/ IT Systems), Process Equipment / Facilities / Utilities and Lab equipment, Shipping Validation, Cleaning Validation, Analytical Test Methods Transfer, Validation or Process Validation.
● Remain abreast of continually evolving GMP regulations and industry practices with particular relevance to applicable areas such as qualification of E/F/U systems, lab equipment and computerized systems, analytical test method validation, shipping validation, cleaning validation or process validation and contribute to the implementation of plans to address any gaps.
● Ensure appropriate validation master plans and validation execution plans related to E/F/U system, lab equipment, computerized systems, analytical test method validation, shipping validation, cleaning validation or process validation in both API and Biologics manufacturing facilities are complying to policies and regulatory requirements.
● Review and approve protocols for initial and subsequent re-qualification programs related to E/F/U system, lab equipment, computerized systems, analytical test method validation, shipping validation, cleaning validation or process validation.
● Work with a cross functional team in providing Quality oversight in E/F/U system, lab equipment, computerized systems, analytical test method validation, shipping validation, cleaning validation or process validation related procedure and ensure compliance to GMP standards, policies, and procedures. Act as one of the key focal points for deviations, change management, investigations, CAPA identification and closure.
About You:
● Degree or higher in Science or Engineering or Pharmacy discipline with at least 6 years of relevant work experience.
● Working experience and knowledge on Commissioning and Qualification of start-ups and brownfield project experience is a plus.
● Hands-on experience in the Validation life cycle of computerized systems is a plus.
● Hands-on experience in establishment and/or maintenance of Cleaning Validation, Shipping
● Validation, Analytical Test Methods Transfer & Validation or Process Validation is a plus.
● Good leadership and communication skills.
● Mentoring and coaching skills.
● Excellent team player willing to work for the common goal.
● Knowledge of pharmaceutical regulatory requirements (GMP) is essential.
● Must become familiar quickly with products and processes in order to assess quality issues.
● Shows a high level of tenacity to ensure closure of issues.
● Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met.
